Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

The Norwegian Lung Cancer Study Group444 enrolled

Overview

The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

444

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

VinorelbineDRUG

Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

GemcitabineDRUG

Day 1: Gemcitabine infusion 1000 mg/m2 Day 8: Gemcitabine infusion 1000 mg/m2

VinorelbineDRUG

Day 1: Vinorelbine capsules 60 mg/m2 Day 8: Vinorelbine capsules 60 mg/m2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-small cell lung cancer stage IIIB or IV * Not eligible for radical radiotherapy or surgery * WHO performance status 0-2 Exclusion Criteria: * Pregnancy * Other clinical active cancer disease * ALAT/ALP more than 3 times upper normal limit, bilirubin \>1.5 upper limit * Bowel disease that causes malabsorption

Locations (4)

Øystein Fløtten

Bergen, Norway

Sverre Fluge

Haugesund, Norway

Heidi Rolke

Kristiansand, Norway

Tore Amundsen

Trondheim, Norway

Outcomes

Primary Outcomes

survival

Time frame: one year

Secondary Outcomes

Health related quality of life (HrQoL)

Time frame: 3 months

Toxicity

Time frame: 3 months

Need for palliative radiotherapy

Time frame: one year

Data from ClinicalTrials.gov

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